Drug Master Files for: felodipine
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felodipine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11449 | A | II | 4/17/1995 | CIPLA LTD | FELODIPINE USP |
| 12248 | A | II | 12/4/1996 | ESTEVE QUIMICA SA | FELODIPINE |
| 13255 | I | II | 10/2/1998 | WOCKHARDT LTD | FELODIPINE |
| 14099 | A | II | 5/3/1999 | MEDICHEM SA | FELODIPINE |
| 14786 | I | II | 3/16/2000 | YANGZHOU PHARMACEUTICAL FACTORY | FELODIPINE |
| 17030 | A | II | 12/10/2003 | EVERLIGHT CHEMICAL INDUSTRIAL CORP | FELODIPINE |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
